{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T01:12:17Z","timestamp":1769217137114,"version":"3.49.0"},"reference-count":10,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2024,2,21]],"date-time":"2024-02-21T00:00:00Z","timestamp":1708473600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:p>After nearly 3 decades of regulatory activity concerning new drugs' potential for delayed cardiac repolarization an integrated risk assessment paradigm for small molecule drugs has been established. Regulatory guidance also suggests that for large, targeted proteins and monoclonal antibodies no quantitative clinical QTc assessment is necessary. The expansion of new drug modalities prompts the question: \u201cShould these new modalities be treated like small molecule drugs or like monoclonal antibodies?\u201d<\/jats:p>","DOI":"10.1002\/cpt.3219","type":"journal-article","created":{"date-parts":[[2024,2,22]],"date-time":"2024-02-22T06:49:12Z","timestamp":1708584552000},"page":"22-25","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["The Efficacy, Effectiveness, and Efficiency of Integrated <scp>QTc<\/scp> Assessment: Rationalizing Approaches to New Drug Modalities"],"prefix":"10.1002","volume":"116","author":[{"given":"Matthew M.","family":"Abernathy","sequence":"first","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Derek J.","family":"Leishman","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,2,21]]},"reference":[{"key":"e_1_2_8_1_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40360-021-00548-0"},{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-16-3083"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1039\/C8TX00261D"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vascn.2020.106900"},{"key":"e_1_2_8_5_1","unstructured":"Jenkinson S(2020) Safety pharmacology society webinar. The use of high\u2010throughput multi ion channel profiling and in silico modeling in assessing arrhythmia risk: one pharma's experience and perspective <https:\/\/vimeopro.com\/safetypharmsociety\/learning\u2010library\/video\/388358505>."},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0199348"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vascn.2008.04.001"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2029"},{"key":"e_1_2_8_9_1","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1002\/cpt.3204","article-title":"Scientific review of the proarrhythmic risks of oligonucleotide therapeutics: are dedicated ICH S7B\/E14 studies needed for low risk modalities?","volume":"116","author":"Qu Y.","year":"2024","journal-title":"Clin. Pharmacol. Ther."},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.3047"}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.3219","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,6,16]],"date-time":"2024-06-16T19:04:56Z","timestamp":1718564696000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.3219"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,21]]},"references-count":10,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2024,7]]}},"alternative-id":["10.1002\/cpt.3219"],"URL":"https:\/\/doi.org\/10.1002\/cpt.3219","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,21]]},"assertion":[{"value":"2023-11-07","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-02","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-21","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}